FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging systems designed for a wide range of clinical applications including obstetrics, abdominal, cardiac, musculoskeletal and more. They produce ultrasound images and enable fluid analysis, incorporating features like Doppler imaging and AI-supported nerve detection to help clinicians make accurate diagnoses in real-time.

FDA #
K220975
Product Code
IYN

The V8 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device that captures real-time images and analyzes body fluids across various clinical applications including obstetrics, cardiac, abdominal, and musculoskeletal imaging. It uses multiple imaging modes and some AI-based software features to assist clinicians in diagnosis and measurement, helping improve accuracy and efficiency in medical imaging.

FDA #
K211945
Product Code
IYN
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